The Committee for Medicinal Products for Human Use is responsible for clarifying the European Medicines Agency’s opinions on medicines for human use. The CHMP conducts the initial assessment of medicines intended for EU-wide marketing based on the quality, safety and efficacy requirements of EU legislation. The following six new medicines met the necessary requirements and were recommended for approval by the CHMP during its June meeting.
Israel-based Teva Pharmaceutical Industries’ Cinqaero is an add-on therapy for adult patients with severe eosinophilic asthma. The drug will be used in instances when high-dose inhaled corticosteroids alone are unable to control the condition, and will require an additional medicinal product for maintenance treatment. The medicines will be available as a 10 mg/ml concentrate for solution for infusion, and its benefits include its ability to reduce the exacerbation rate and improve lung function.
Teva’s Aerivio Spiromax and Airexar Spiromax
The CHMP approved a further two medicines from Teva, the hybrid medicines Aerivio Spiromax and Airexar Spiromax. The medicines are used for the treatment of asthma and Chronic Obstructive Pulmonary Disease, and are a combination of fluticasone propionate and salmeterol xinafoate. Both will be available as a single high-strength 50µg/500µg inhalation powder. The benefits of both medicines are their abilities to improve pulmonary function and symptoms, in addition to reducing exacerbations.
Mylan N.V.’s generic drug Atazanavir Mylan, an antiviral used to treat HIV-1, was also approved. Atazanavir Mylan is a generic version of Bristol-Myers Squibb’s Reyataz drug, and is co-administered with AbbVie’s Norvir which contains the active substance Ritonavir, an antiretroviral medication. Atazanavir Mylan will be available as hard capsules of 150 mg, 200 mg and 300 mg. The active substance of Atazanavir Mylan is atazanavir, an inhibitor of the viral protease enzyme which is key for viral replication.
Molecular Medicines, also known as MolMed, was granted conditional marketing authorization for its drug Zalmoxis, an advanced therapy medicinal product. The drug will be used as an add-on treatment for adult patients receiving haploidentical haematopoietic stem cell transplants (HSCT) for blood cancers. Zalmoxis aids immune reconstitution and reduces the threat of graft-versus-host disease. The drug has an orphan designation. Research has shown that Zalmoxis is able to increase overall survival rates of patients, with 45 patients receiving treatment showing a survival rate of 49% after one year of treatment, compared to 140 patients who had undergone haploidentical HSCT treatment without Zalmoxis, resulting in a survival rate of 37%.
The CHMP also granted marketing authorisation to the Nordic Group for the product Nordimet. The active substance of Nordimet is methotrexate, an antimetabolite folic acid analogue. It is intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe recalcitrant disabling psoriasis. Nordimet will now be available as a solution for injection (7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg).
The approval of the six new medicines by the Committee for Medicinal Products for Human Use will come as good news for millions of people around the world. These medicines will improve the quality of life for people suffering from debilitating diseases such as HIV-1 and Chronic Obstructive Pulmonary Disease. As we saw in yesterday’s Analyst Q&A, the healthcare sector is evolving at a fast pace resulting in new techniques, therapies and medicines, so expect the CHMP to have their work cut out for them during the coming years.
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